Mussels, Inflammation and Rheumatoid Arthritis (MIRA)

Rheumatoid Arthritis Clinical Trial

— MIRA  

Official title:

Mussels, Inflammation and Rheumatoid Arthritis (MIRA)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02522052
• Other study ID #: GotenburgU
• Status: Completed
• Phase: N/A
• First received: April 29, 2015
• Last updated: August 14, 2017
• Start date: August 2015
• Est. completion date: May 2016

Study information

• Verified date: August 2017
• Source: Göteborg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Rheumatoid arthritis (RA) is a chronic disease that affects ~1% of the population. A large proportion of patients with established disease have persistent high disease activity in spite of existing effective pharmacological treatment. Improved treatment is thus urgently needed, including alternative treatments in addition to optimal pharmacological therapy. The main purpose of this study is to investigate if a high intake of blue mussel (Mytilus Edulis) could decrease inflammation and disease activity in patients with established RA. A secondary goal is to identify novel biomarkers for blue mussel intake and metabolic responses to this diet, using a metabolomics approach with high sensitivity and specificity. A third goal is to look at genetic polymorphisms in relation to long chain polyunsaturated fatty acids (LCPUFA) and inflammatory markers.

Description:

Rheumatoid arthritis (RA) is a chronic disease that affects ~1% of the population. A large proportion of patients with established disease have persistent high disease activity in spite of existing effective pharmacological treatment. Improved treatment is thus urgently needed, including alternative treatments in addition to optimal pharmacological therapy. The main purpose of this study is to investigate if a high intake of blue mussel (Mytilus Edulis) could decrease inflammation and disease activity in patients with established RA. A secondary goal is to identify novel biomarkers for blue mussel intake and metabolic responses to this diet, using a metabolomics approach with high sensitivity and specificity. A third goal is to look at genetic polymorphisms in relation to LCPUFA and inflammatory markers.

Diet and lifestyle are associated with chronic diseases such as cardiovascular diseases, cancer and diabetes. Here, evidence based dietary treatment guidelines are available. In contrast, for inflammatory diseases such as RA no dietary guidelines exist, reflecting the ambiguous evidence base. Many dietary components are related to the human immune system or to inflammation. Some are co-factors in immune- or inflammatory response, such as zinc. Others are antioxidants, eg selenium, vitamins E and C. RA has been associated with low serum concentrations of zinc, selenium, vitamins D and B6 although some of this may reflect inflammatory response. Dietary effects on RA symptoms have been reported for long chain fatty acids from fish and probiotics have shown to improve function in RA patients. As prebiotics reduce inflammation in other conditions, it may have positive effects also on RA. Most research on antioxidants has focused on single nutrients but a few dietary trials also have been conducted with mixed results. In sum, high-quality studies evaluating the effect of a combination of food items with indicative effects on RA are needed.

Blue mussels are rich in vitamins (B2 and B12) and minerals (iron, selenium and zinc) and contain the LCPUFA eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 65 Years

Eligibility

Inclusion Criteria:

• BMI 18-40 kg/m2,

• disease duration >2 years,

• DAS28 >3.0

Exclusion Criteria:

• other Life-threatening disease,

• pregnant,

• lactating,

• food intolerant or allergic to food included in the study.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Inflammation
• Rheumatoid Arthritis

Intervention

Other:
• Blue mussel diet
5 meals a week containing blue mussels
• Meat/Control diet
5 meals a week containing meat

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital	Göteborg	Not in US/Canada

Sponsors (2)

Lead Sponsor	Collaborator
Göteborg University	Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Difference in plasma and RBC fatty acids after the diets and changes during the diets	Fatty acids in plasma and red blood cells (RBC)	after 11 week intervention
Other	Differences between blood lipids (TAG, HDL, LDL) after the diets	Serum analysis of TAG, HDL, LDL	after 11 week intervention
Other	Differences in Hb after the diets	Blood status (Hb)	after 11 week intervention
Other	Eular response criteria	To interpret effects on DAS28	after 11 week intervention
Other	Stable isotopes in hair	stable isotopes	after 11 week intervention
Primary	difference between disease activity score 28 (DAS28) after the diets	Measured clinically	after 11 week intervention
Secondary	difference in inflammatory markers/cytokines (IL-1beta, IL-6, Tumor Necrosis Factor-alfa, IL-10) after the diets	measured in blood	after 11 week intervention
Secondary	Difference in Quality of life and health by SF36, EQ5D och HAQ after the diets	Measured by validated instruments (SF36, EQ5D och HAQ)	after 11 week intervention
Secondary	Differences and changes in metabolites after the two diets	Metabolomics Nuclear magnetic resonance (NMR) analysis of serum and urin samples.	after 11 week intervention